In a fundamental shakeup of chemical drug classifications in China, foreign imported products are now in a class of their own while domestic drugs will be considered generics unless they are NCEs or have new formulations or indications. The changes are set to change the competitive landscape in profound ways, industry observers predict.
BEIJING - Like a stone being thrown into a pool of calm water, the China FDA released on March 9 “Document 51, Reform Plans for Chemical Drug Registration”, stirring up immediate reactions from the pharma industry.
Although the CFDA had in late 2015 decided to narrow the definition of "new drugs", the agency provides further details...
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